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  • Competent Authority Reporting


    I am looking over what to report to the competent authority for adverse incidents.  I am happy that with the information supplied by Advisera my quality manual covers that.  

    I am curious about a situation though, we purchase a class 1 device from the manufacturer and sell it.  Our customer has purchased 10 this last year and 3 have broken.  I suspect it is their handling of the device.  They believe this should be reported to the competent authority (MHRA in our case) as a product defect.  

    Does anyone have advice on this?  if it was a IIa or b I would possibly understand, but I am unsure here.  No adverse incident has occured from this, no one has been harmed.

  • OQC Standard as Importer

    Hello again,


    I'm preparing ISO 13485 QMS as Importer in Europe. Our scope of work is "Sales, Logistics and Warranty Service".

    To ensure safety and quality of our product, we should conduct outcome inspection (OQC) after we repair the defective devices or reworks.

    However, we do not have any inspection standard or test report forms yet. 


    The question is, "Do we have to have identical inspection standard(criteria) and OQC test report as our Manufacturer?"


    Any feedback would be very appreciated. 

  • ISO 13485 as Importer



    I'm preparing to get ISO13485 certified as Importer. 

    We are importing medical devices (class I) in Europe, implement warranty service and sell to EMEA/CIS area. 

    I know it's not a requirement to get ISO13485 as Importer but we should get it by main customer's request. 


    In this case, There are several questions I would like to ask. 

    1. How should I set the scope of ISO 13485 certificate? Development & Manufacturing will be excluded as we only implement procurement, sales, warranty service and storage.


    2. How far should I create procedures? I don't think we need to conduct all the activities what ISO13485 requires. 


    3. For example to be more specific, how do we manage risk management? 

    Our headquarter(Legal Manufacturer) already conduct risk management activities and have relavent risk management files.

    Do we have to make risk management procedure? can we just monitor those risk management files implemented by our HQ?

    or do we have to do process risk assessment? (e.g. risk assessment for each procedure) 


    Your feedback would be very appreciated.


  • Filling documents

    1. On the risk management matrix, should we include departments such as finance and administration that are not quite an essential part of the process to make and develop our product?

    2. On the 9th document "Design and Developempent" there says we should include record of old versions of the designs of the product, but our question is how much records should we include? Should we include since our first design (which is from 2021) or could we just include the designs from a year ago to now? Or is there a minimum record time that must be met?

  • Distributor and ISO 13485

    I am revising the Distributor's Agreement and wondering to what extent our quality control shall go to ensure the ISO 13485?
    In other words, how much can I ask of the distributor in terms of complying with ISO 13485? 
    Should the medical device distributor have ISO certification or only knowledge of it?

  • Internal auditor selection

    We come across this clause in the Internal Audit procedure: 

    [Job title] selects auditors in such a way as to ensure objectivity and impartiality, i.e. to avoid conflict of interest, because auditors are not allowed to audit their own work.

    Given that our company is quite small, all employees are doing work relating to the ISO and therefore, an internal auditor may encounter something in the audit relating to their own work. Furthermore, the candidates that are able to assess all sides of the procedures (including the R&D technical side) are limited.

    Does this mean that we have to hire an external auditor?

  • MDR classification

    Best MDR classification of a non-invasive, low power (8mW pulsed at 10% duty cycle) near infrared sensor applied to skin (hand web) in a transitory fashion for use over extended periods of time?

  • Drug-device combination product development and manufacturing

    My main question is what is the regulation or what level of ISO 13485 should be compliance for Drug-device combination product development and manufacturing, ie the pen-injector or auto-injector for insulin or other drug? 

  • Risk Management Question

    We've been filling the risk management table on the 06th document but we have a question: ¿which processes should we include? Because we have many processes such as R&D, operations, production, QA, sales, delivery etc. but we wonder which ones should we include?

  • How long and how much for emdr 2a certification of software ai as medical device?

    How long and how much for emdr 2a certification of software ai as medical device?

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